On February 16, 2024, the U.S. Department of Health and Human Services (“HHS”) published a final rule to amend the Confidentiality of Substance Use Disorder (“SUD”) Patient Records regulations (“Part 2”) to more closely align Part 2 with the Health Insurance Portability and Accountability Act of 1996, as amended, and its implementing regulations (collectively, “HIPAA”)

On Tuesday, February 9, the Substance Abuse and Mental Health Services Administration (SAMHSA) published a proposed rule to update regulations at 42 C.F.R. Part 2 that protect the confidentiality of alcohol and drug abuse patient records.  The regulations were originally promulgated in 1975 and last substantively updated in 1987.  SAMHSA intends for these updates to better align the regulations with advances in the U.S. health care delivery system, such as health information technology.


The regulations at 42 C.F.R. Part 2 (“Part 2 regulations”) protect the confidentiality of patient records that are maintained in connection with the performance of any federally assisted program or activity relating to substance abuse education, prevention, training, treatment, rehabilitation, or research.

The goal of the regulations is to ensure that individuals are not deterred from seeking treatment for substance abuse disorders out of concern about the potential disclosures of these records.  SAMHSA notes that unauthorized disclosure has the potential for significant negative consequences for patients, such as: loss of employment, loss of housing, loss of child custody, discrimination by medical professionals and insurers, arrest, prosecution, and incarceration.

To safeguard substance abuse treatment records, Part 2 regulations require that a patient consent to the disclosure of individually identifiable information related to diagnoses, treatment, or referrals by federally assisted substance abuse programs, except in certain limited circumstances, such as a bona fide medical emergency, for research purposes, for audit and evaluation activities, and pursuant to a court order.

SAMHSA proposes the following changes to the regulations:
Continue Reading SAMHSA Proposes Changes to Confidentiality Rules